INDICATION

EVENITY™ is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Read More

available osteoporosis therapy. The anabolic effect of EVENITY™ wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY™ use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close

Patients taking EVENITY™ during the first 12 months followed by Prolia® (denosumab) had significantly fewer vertebral fractures than those taking placebo followed by Prolia®1

EVENITY™ First Followed by Prolia® vs Placebo Followed by Prolia®1
Fracture Risk Reduction at 12 and 24 Months

NEW VERTEBRAL FRACTURES

Vertebral Fractures
  • The incidence of nonvertebral fractures was not statistically significantly different when comparing EVENITY™-treated women to placebo-treated women at month 12 or month 241

*Absolute and relative risk reduction are based on the Mantel-Haenszel method adjusting for age and prevalent vertebral fracture strata.

P value based on logistic regression model adjusting for age and prevalent vertebral fracture strata.

ARR = absolute risk reduction.

EVENITY™ rapidly built bone in just 12 months1

Significant BMD gains at key sites1

When followed by Prolia® (denosumab), BMD gains were maintained through 24 months1

EVENITY™ First Followed by Prolia® vs Placebo Followed by Prolia®1,2

BMD Gains at Month 12 and Month 24

LUMBAR SPINE

Lumbar Spine

* P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

TOTAL HIP

Total Hip

* P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

FEMORAL NECK

Femoral Neck

* P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

Bone biopsies: Bone volume and structure at 12 months3

Micro-CT images of bone biopsies3

Placebo Bone Biopsy
  • Trabecular bone volume increased and trabeculae became thicker and more plate-like
  • Cortical thickness increased

For illustrative purposes only. Bone biopsies are from a substudy consisting of 139 women with postmenopausal osteoporosis. Images selected are from different patients (one with untreated osteoporotic bone and one after treatment with EVENITY™) who had Tb.BV% values close to the group mean.3

Tb.BV = trabecular bone volume.

EVENITY™ VS ALENDRONATE EFFICACY EVENITY™ VS TERIPARATIDE EFFICACY

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY™ should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY™ should be discontinued.

Back to Top

References: 1. EVENITY™ (romosozumab-aqqg) prescribing information, Amgen. 2. Data on file, Amgen. 2016. 3. Data on file, Amgen. 2019.